The European Medicines Agency (EMA) released a guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic. The overall aim is to accelerate and simplify the procedures for the development of COVID-19 [...]
On May 14-16th over 1,500 people from 57 different countries, representing all stakeholder groups in the rare disease community, joined together at the 10th European Conference of Rare Diseases & Orphan Products — ECRD 2020. EPTRI, an EU-funded project coordinated by CVBF, was glad to attend such an important event presenting a poster entitled “European Paediatric [...]
International Clinical Trials Day is held on 20 May each year since 2005 to commemorate the day that James Lind began his famous trial for the scurvy. The objective is to make this moment a focal point for international communication events, meetings, debates, and celebrations of clinical research. This year, in occasion of the event, [...]
Covid-19 pandemic is representing an unprecedented challenge for the governments and their healthcare and economical systems, who are working hardly to develop the proper legislative tools to face the emergency. This results in a heterogeneity of dispositions and regulations in the different States, although the European Medicines Agency (EMA) is periodically releasing recommendations and guideline [...]
Due to the progress of the situation related to the new coronavirus infection and the declaration of the pandemic status by the WHO, the management team analysed the practicability to organise the EPTRI Open Meeting on the 2nd and 3rd of April 2020 in Brussels. To guarantee the safely participation of everybody and the contribution to this crucial [...]
The EUCROF Events&Training Working Group, which Chair is our CEO Dr Donato Bonifazi, presents the webinar “Traceability in Clinical Trials: Challenges of the new EU TMF/eTMF Guideline” that will be held on 28 April 2020 (from 10:00 to 11:30 CET). The webinar offers an overview of the EU Guideline on electronic Trial Master File (eTMF) [...]
Since the terrible stress upon hospitals and ICUs is one of the greatest challenges the disease created, and for now possibly the most crucial point for saving life, once a person gets ill, The State of Israel is establishing a central data center, where medical electronic records (ER) of the COVID-19 patients, and particularly the [...]
A pneumonia of unknown cause detected in Wuhan, China was first reported to the World Health Organisation Country Office in China on 31 December 2019. After just three months WHO characterised COVID-19 as pandemic, currently affecting 157 countries and territories around the world. Besides the impact on international financial market and individual social life, COVID-19 [...]
On March 2020, the European Medicines Agency released its annual overview of the involvement of patients and healthcare professionals in the work of the Agency. The report underlined a high percentage (90%) of cases, in which coordinators of scientific advice procedures considered patient involvement as a key action in their decision-making process. Several events have [...]
The Italian Ministry of Health presented the new website www.malattierare.gov.it dedicated to rare diseases to collect all the reference points on the Italian territory for rare patients. It is estimated that over one million rare patients live in Italy, while around 325 thousand patients are registered in the National Register of Rare Diseases, which reports [...]